3. Compositional Aspects

Food Supplements
Australia

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

Listed Complementary Medicines AUST L

Ingredients must be drawn exclusively from a pre-approved list, the Permissible Ingredients List [1] which is updated regularly. This is a positive list and the use of ingredients must meet the requirements outlined under each permission.

More details on each ingredient can also be accessed on the TGA electronic business services portal (TBS) [2] by selecting the 'Ingredients' tab in the menu. Searches can be done using CAS numbers, common names, or scientific names. Once an ingredient of interest is found, an Ingredient Summary can be obtained by clicking on the link. These summaries include the Australian Approved Name (AAN), CAS number, permitted uses (active and/or excipient and types of medicines they can be used in), any quantity restrictions, and required label advisory statements. 

The TGA has a guideline on the Permissible Ingredients list [3]. When there is a difference between the TBS ingredient summary and the Permissible Ingredients List, the latter takes precedence.

Listed Assessed Complementary Medicines AUST L(A)

Same as above.

Registered Complementary Medicines AUST R

Ingredients must be drawn from the pre-approved list described above and can also include those in a schedule to the Poisons Standard (except for those in Schedules 4, 8 or 9). Some Registered products have the same types of ingredients as AUST L medicines but are registered due to the use of high-level indications for the products.

The Poisons Standard contains classifications of medicines and poisons into Schedules for inclusion in the relevant legislation of the states and territories. The Schedules are used for human and animal medicines and industrial chemicals. It includes provisions about containers, labels, and controls on availability (e.g. Schedule 4 is Prescription Only Medicines; Schedule 3 is Pharmacist Only). 

Registered Complementary Medicines are expected to contain non-prescription ingredients, such as Pharmacy Only (Schedule 2) and Pharmacist Only (Schedule 3) although a few ingredients are included in other schedules. A short description of each schedule is provided in Ref [4]. 

Please refer to additional notes in section 3.8.

3.2 Raw Material Requirements

Compendial standards

Clause 3 of the Act [5] describes Default standards, which are any of the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopoeia-National Formulary. If an ingredient is subject to a default standard then you need to comply*.  

For ingredients, the provisions of the General monographs and General chapters of the default standards also apply (e.g., in relation to pesticides, residual solvents, heavy metals, etc.). 

From time to time, the Minister may make an alteration to a default standard under Section 10 of the Act [5]. For example, TGO 93 [6] makes such a standard for medicinal cannabis. It shall be noted that there are no current such Ministerial alterations for any ingredients used in Complementary medicines.

*Applications can be made under section 14 of the Act for permission of goods that do not comply with a default standard [7].

Non-compendial standards

For ingredients where there is no default standard, the TGA may publish Compositional Guidelines [8] describing the tests, analytical procedures, and acceptance criteria. Unfortunately, there is not a compiled list of these guidelines, however, they can be accessed via the provided landing page. 

Notes for finished products:

The information provided above regarding Compendial standards (default standards such as the BP, Ph Eur, USP/NF) for raw materials also applies to finished products where there is a monograph for the substance and dose form, including the application of the General monographs and General chapters. These are the chapters in each pharmacopeia (e.g., the USP/NF) which cover general items such as heavy metals testing, standards for tablets, Residual solvents, etc.

The TGA also has its own standard for tablets, capsules, and pills [9] which describes the requirements for both general monographs in the Default standards and Australia-specific requirements (Clause 8) and also covers requirements for products containing folic acid (Clause 10), dissolution testing (Clause 11), Uniformity of dosage units and weight (Clause 12), and various other local requirements.

TGO 100 [10] outlines the microbiological requirements for finished products. 

A non-sterile medicine, other than a complementary medicine (in oral dosage form) containing raw material of natural (i.e., animal, vegetal, or mineral) origin, must comply with the relevant acceptance criteria for microbiological quality in the standards described in Clause 11 (1). Otherwise, the requirements set out in Schedule 1 or 2 as described in Clause 11 (2) apply. Raw materials do not have to comply with TGO 100; instead, the general chapters of the default standards apply, along with any ingredient-specific monograph requirements.

3.3 Fortification

N/A.

3.4 Other Permitted Ingredients  

Colorings

Ingredients such as excipients that have a natural coloring effect may be used provided they have an entry in the Permissible Ingredients list [1]. For example, a fruit extract such as Vaccinium Myrtillus (bilberry) could be used. Such ingredients can be found using the ingredients search on the TBS portal [2] as described above. 

Table 2 in the TGA guidance on colors used in topical and oral products [11] lists other permitted coloring substances and any relevant restrictions for their use. The guidance also outlines the relevant standards to be applied to coloring substances and applications for new coloring substances. Please refer to the additional notes in section 3.5. 

Herbal Ingredients

There are special requirements for ingredients derived from plants. Some ingredients are Approved Herbal Substances (AHS) such as cinnamon powder, clove bud oil, and peppermint leaf dry. These types of herbal ingredients need to meet any monograph in a default standard. 

Herbal substances are described in Regulation 2 [12] as: “all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin): 

(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol, or aqueous ethanol; and 

(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.”

For other herbal ingredients, the plant undergoes processing such as a decoction, liquid extract, or concentrated extract. Such ingredients are given an Australian Herbal Name (AHN) (e.g., Camellia sinensis) which then has to have the plant part (e.g., leaf) and preparation process (e.g., extract dry concentrate) added to give the full ingredient name e.g. Camellia sinensis leaf extract dry concentrate. Such extracts may also be standardized to particular relevant components which can be quantified to a herbal component.

In some cases, a supplier manufactures a herbal extract with a proprietary formula (Active Herbal Extract) which is a type of PI. This is only eligible for use in a Complementary medicine if it contains only one herb which meets the definition above of a 'herbal substance'. Further information on plant-derived ingredients is available on this webpage [13] under 'Guidelines on herbal materials and extracts'.

3.5 Permitted Additives

Additives apart from colorings and flavorings are all the ingredients permitted as excipients as described above. Many food ingredients (e.g., honey, whey powder) and food additives (e.g., acacia/gum Arabic, carnauba wax) are included in the Permissible ingredients list [1]. Processing aids, such as solvents, can be used provided they are in the permitted list [1]. For example, solvents such as ethanol, ethyl acetate, etc., can be used provided they are on the list and any residual solvents requirements, as described above, are met. 

Note that since Complementary medicines are not food, ingredients are not 'additives' but are excipients.

3.6 Permitted Flavors and Colors 

For flavoring substances permitted as part of a Proprietary Ingredient (refer to additional notes in section 3.8), there is a limit on the total concentration allowed in listed medicines of 5% [14, Table 1]. Most flavors permitted as excipients [ref 2] are permitted for use only in combination with other permitted ingredients as a flavor.

For colorings, check section 3.4 above.

3.7 Permitted Processing Aids 

None.

3.8 Additional Notes 

Scheduling of ingredients

It should be noted that the scheduling of ingredients is not always a question of scheduled/unscheduled. Some ingredients can be both unscheduled and scheduled and can also appear under different schedules of the Poisons Standard. For example, Cholecalciferol (Vitamin D3):

- it is unscheduled when used in medicine to provide 25 mcg or less per day (when for internal use). Therefore, at these levels, it can be used in a Listed complementary medicine, a Listed Assessed complementary medicine, or a Registered complementary medicine.

Vitamin D can also be Scheduled:

-it is in Schedule 3 (Pharmacist Only) when for internal use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose (except for preparations containing 25 micrograms or less per recommended daily dose). This is only permitted for Registered Complementary medicines.

- it is in Schedule 4 (Prescription Only) when not in Schedule 3 or unscheduled. This is not permitted for any Complementary medicine categories.

This means that a Listed (AUST L or AUST L(A)) Complementary medicine could contain Vitamin D3 at a level to provide 25 mcg or less per day. A Registered (AUST R) Complementary medicine could provide any level of Vitamin D3 up to 175 micrograms or less of vitamin D per recommended single weekly dose or up to 25 mcg or less per day. 

Proprietary ingredients (PIs)

A proprietary ingredient is a commercial mixture of ingredients where the formulation may or may not be confidential. A PI may be an excipient mixture or an active premix. These are given a PI name and Number by the TGA to enable sponsors to enter the information into a medicine application more easily. Examples are flavorings, fragrances, printing inks, and confidential herbal Active Herbal Extracts. All components of PIs must be in the Permissible Ingredients list. More guidance is available on the webpage [15].

3.9 References

1. Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022

https://www.legislation.gov.au/Details/F2022L01528/Download (Note: there are six volumes and an explanatory statement)

2. TGA Electronic business services portal (TBS) 

https://www.ebs.tga.gov.au/

3. Guideline - Introduction to the Permissible Ingredients Determination, ver 1.0, December 2020 (PDF provided)

4. Poisons Standard October 2022

https://www.legislation.gov.au/Details/F2022L01257/Download

5. Therapeutic Goods Act 1983

https://www.legislation.gov.au/Details/C2021C00376/Download

6. Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Amendment Order (No. 2) 2022

https://www.legislation.gov.au/Details/F2022L01569/Download

7. Consent to import, supply, or export therapeutic goods that do not comply with standards

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good-0/supply-prescription-medicine/application-types/consent-import-supply-or-export-therapeutic-goods-do-not-comply-standards-information-industry

8. TGA Compositional Guidelines

https://www.tga.gov.au/resources/resource/compositional-guidelines

9. Therapeutic Goods (Standard for Tablets, Capsules, and Pills) (TGO 101) Order 2019

https://www.legislation.gov.au/Details/F2020C01070/Download

10. Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

https://www.legislation.gov.au/Details/F2022C00360/Download

11. Colourings used in medicines for topical and oral use, version 2.2, August 2018 (PDF provided)

12. Therapeutic Goods Regulations 1990

https://www.legislation.gov.au/Details/F2023C00011/Download

13. Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines 

https://www.tga.gov.au/resources/publication/publications/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines

14. Quality for listed medicines, Australian regulatory guidance, version 1.0, May 2020. (PDF provided)

15. TGA - Proprietary Ingredients

https://www.tga.gov.au/how-we-regulate/ingredients-and-scheduling-medicines-and-chemicals/proprietary-ingredients